LSL · Class II · 21 CFR 866.3390

FDA Product Code LSL: Dna-reagents, Neisseria

Leading manufacturers include Gen-Probe, Inc., Becton, Dickinson & CO and Roche Molecular Systems, Inc..

45
Total
45
Cleared
215d
Avg days
1987
Since
45 devices
25–45 of 45
Cleared Dec 24, 2003
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
K032194
Gen-Probe, Inc.
Microbiology · 159d
Cleared Sep 18, 2001
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351
Becton, Dickinson & CO
Microbiology · 55d
Cleared May 21, 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395
Gen-Probe, Inc.
Microbiology · 201d
Cleared Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503
Roche Molecular Systems, Inc.
Microbiology · 733d
Cleared May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342
Roche Molecular Systems, Inc.
Microbiology · 556d
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833
Abbott Laboratories
Microbiology · 881d
Cleared Oct 31, 1994
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979
Gen-Probe, Inc.
Microbiology · 244d
Cleared Apr 26, 1994
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301
Gen-Probe, Inc.
Microbiology · 826d
Cleared Nov 14, 1989
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
K895583
Gen-Probe, Inc.
Microbiology · 60d
Cleared Apr 25, 1988
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
K881277
Gen-Probe, Inc.
Microbiology · 38d
Cleared Mar 01, 1988
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE
K874620
Gen-Probe, Inc.
Microbiology · 113d
Cleared Dec 21, 1987
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
K872628
Ortho Diagnostic Systems, Inc.
Microbiology · 168d